Pioneering Global Safety Medical Director – Rare Disease

BioSpace; Washington (District of Columbia); Hybrid; USD 260,000 - 360,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Stock incentives

Paid time off

Flexible work models

Job summary

Amgen is hiring a Global Safety Officer, Medical Director for Rare Disease to lead safety strategy across early development. You will chair safety governance, guide pharmacovigilance activities, and influence development decisions with cross-functional partners.

The role requires MD/DO with extensive drug safety leadership, experience in Phase 1b/2 programs, and a track record of regulatory interactions. Travel up to 10% is anticipated.

Qualifications

• MD or DO degree from an accredited medical school.
• Completion of an accredited medical or surgical residency.
• Relevant clinical experience in academic, hospital-based, or private practice settings.

Responsibilities

• Serve as the accountable physician safety leader for assigned Rare Disease development programs.
• Lead global safety strategy for clinical development programs with a primary focus on Phase 1b and Phase 2 studies.
• Partner with Clinical Development and Translational Medicine teams to inform dose-escalation, cohort expansion, proof-of-concept, and development decisions.
• Provide medical safety leadership and contribute to benefit-risk evaluations throughout clinical development.
• Review and interpret emerging safety data and communicate safety implications to development teams and governance committees.
• Lead Safety Analysis Team (SAT), Global Safety Team (GST), and participate in Executive Safety Committee (ESC) discussions.
• Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums.
• Validate safety signals and lead signal detection, assessment, and risk evaluation activities.
• Develop and maintain Core Safety Information including Core Data Sheets and informed consent safety language.
• Prepare and review Risk Management Plans (RMPs), risk minimization strategies, and aggregate safety reports.
• Lead safety review and provide strategic input into protocol development, CRF design, Statistical Analysis Plans, Clinical Study Reports, and safety monitoring plans.
• Prepare and review safety sections of regulatory submissions including INDs, CTAs, BLAs, NDAs, and other global submissions.
• Serve as the safety representative on Evidence Generation Teams and other cross-functional development teams.
• Support regulatory inspections and inspection readiness activities.
• Domestic and international travel up to 10%.

Skills

Global safety leadership

Phase 1b/2 development

Safety governance

Signal detection

Regulatory submissions

Education

MD or DO degree

Residency training

Relevant clinical experience

Job description

Amgen is hiring a Global Safety Officer, Medical Director for Rare Disease to lead safety strategy across early development. You will chair safety governance, guide pharmacovigilance activities, and influence development decisions with cross-functional partners.

The role requires MD/DO with extensive drug safety leadership, experience in Phase 1b/2 programs, and a track record of regulatory interactions. Travel up to 10% is anticipated.